1. Field of the Invention
The present invention relates in general to the field of dilatation or balloon catheters employed in the treatment of vascular diseases. More particularly, the present invention relates to a low-profile single-lumen perfusion balloon catheter with an axially extending external perfusion conduit having a perfusion lumen traversing the dilatation balloon of the catheter. This perfusion conduit extends only a short distance along the length of the catheter and includes distal and proximal perfusion ports on opposite sides of the dilatation balloon communicating with one another via a lumen of the perfusion conduit. This perfusion conduit at the distal end portion of the catheter also facilitates mono-rail use of the catheter for catheter exchange purposes, if desired.
2. Related Technology
Over the past decade the medical procedure known as angioplasty has become widely accepted as a safe and effective method for treating various types of vascular diseases. For example, angioplasty is widely used for opening stenoses throughout the vascular system and particularly for opening stenoses in coronary arteries.
At present, the most common form of angioplasty is called percutaneous transluminal coronary angioplasty (PTCA). This procedure utilizes a dilatation catheter having an inflatable balloon at its distal end. By using a fluoroscope and radiopaque dyes and markers on the catheter for visualization the distal end of the dilatation catheter is guided into position through a guide catheter and across the stenosis. With the dilatation balloon in this position of alignment with the stenosis the balloon is inflated for a brief duration to open the artery and establish adequate blood flow.
Typically, inflation of the balloon is accomplished by supplying pressurized fluid from an inflation apparatus located outside the patient's body through an inflation lumen in the catheter which communicates with the balloon. Conversely, applying a negative pressure to the inflation lumen collapses the balloon to its minimum dimension for initial placement or for removal of the balloon catheter from within the blood vessel receiving treatment.
In the past years a number of balloon catheter designs have been developed which have contributed to the safety and acceptability of PTCA and similar medical procedures. The most common design is known as an "over-the-wire" balloon catheter. This conventional device typically utilizes a relatively large lumen for passage of a guide wire and injection of contrast fluid (or angiographic visualization dye) to assist in the placement of the device. A second parallel lumen is provided for inflation and deflation of the balloon.
Typically, a steerable guide wire is positioned within the larger lumen and the entire assembly is maneuvered into an initial position within the target artery through a guide catheter which has been positioned previously, and which is of sufficient diameter to pass the angioplasty catheter. Once near the site of the stenoses the guide wire can be rotated and axially extended or retracted into position across the lesion. The therapeutic angioplasty catheter is subsequently advanced along the guide wire to position its balloon end portion across the lesion prior to inflation of the balloon and dilatation of the stenosis.
An alternative conventional over-the-wire catheter assembly utilizes a non-removable guide wire that allows for longitudinal or axial movement. However, this design has a significant drawback because the entire catheter assembly with its non-removable guide wire must be removed to accomplish replacement or exchange of the balloon. In some cases of PTCA it is necessary to replace the balloon with one of different diameter or configuration following the initial dilatation.
However, cases of acute re-closure have been noted where the lesion closes again following dilatation and removal of the balloon catheter. One response to this re-closure problem has been the placement of an expandable stent into the artery at the lesion with another replacement balloon catheter. This alternative system increases the difficulties of these subsequent procedures by requiring that the replacement catheter renegotiate the entire placement path without the advantage of a guide wire.
A "mono-rail" variant of the standard balloon-over-a-wire system also has been developed in which only the distal portion of the balloon catheter tracks over the guide wire. This system utilizes a conventional inflation lumen and a relatively short guiding or through lumen adjacent to the distal end of the catheter. Principal benefits of the monorail construction of therapeutic catheter are the reduction of frictional drag over the length of the externally located guide wire and the ease of balloon exchange. This construction provides the ability to recross an acutely closed vessel or to exchange balloons without removing the guide wire.
However, a disadvantage of this "mono-rail" design is the increased difficulty in steering the guide wire because the guide wire is not supported by the balloon catheter. Also, the balloon catheter itself may not be pushable to move along the guide wire. Some versions of the monorail use an external flexible pusher member which also tracks the guide wire and is used to move the therapeutic catheter to the desired location near the distal end of the guide wire. Additionally, the dual lumen distal design of the monorail catheters produces a larger profile and catheter shaft size.
Another innovation in dilatation catheter design which is now conventional is the "fixed-wire" or integrated "balloon-on-a-wire" dilatation catheter. These single lumen designs utilize a relatively narrow wire positioned within the inflation lumen and permanently fixed to the distal end of the balloon. This construction produces a low-profile catheter assembly which is able to cross severely narrowed lesions and to navigate tortuous vascular pathways. Additionally, the fixed guide wire bonded at the distal end of the balloon improves the steerability and pushability of these designs which enhances their maneuverability. The thin shaft design also improves coronary visualization and enables all but the tightest critical lesions to be crossed.
However, though able to provide relatively quick and simple balloon placement as well as providing access to lesions otherwise unsuitable for PTCA, fixed-wire balloon-on-a-wire systems sacrifice the ability to maintain guide wire position across the lesion when exchanging balloons or the safety advantage of being able to recross an acutely closed vessel without repositioning the entire assembly.
Yet another difficulty arises when the dilatation balloon is inflated to dilate the vessel under treatment. While this balloon is inflated blood cannot circulate in the vessel. This lack of blood circulation can lead to necrosis of tissues already stressed by the previously reduced level of blood flow. As a solution to this problem, catheters have been provided with perfusion ports proximal and distal to the balloon and communicating with one another via a lumen of the catheter which extends through the balloon.
A conventional catheter of the type discussed immediately above is known in accord with U.S. Pat. No. 4,581,017, issued 8 Apr. 1986 to H. Sahota. This catheter is believed to include an elongate tubular shaft defining a guide wire and perfusion lumen, and an inflation lumen. A dilatation balloon is carried on the tubular shaft near the distal end thereof, and communicates with the inflation lumen. In order to allow perfusion blood flow past the inflated balloon, the catheter shaft defines at least one proximal and at least one distal perfusion port opening outwardly from the guide wire and perfusion lumen on opposite sides of the balloon. When the balloon is inflated to dilate the lesion, perfusion blood may flow through the guide wire lumen past the balloon.
Another conventional catheter also of this type is depicted in U.S. Pat. No. 5,160,321, issued 3 Nov. 1992, to H. Sahota. The catheter depicted in the Sahota patent employs a separate inner lumen to outwardly bound an annular axially extending passage through which blood may flow past the inflated balloon via perfusion ports. Also, this separate inner lumen inwardly defines a passage through which extends the guide wire assembly for the catheter.
However, with catheters of the type illustrated by the Sahota patents, and others of this type, the distal portion of the catheter is obstructed by the guide wire, or by the guide wire and its lumen. Consequently, the cross sectional area of the catheter lumen which is available for blood perfusion past the inflated balloon is very limited. While the distal end portion of the catheter may be made of a size sufficient to pass an adequate volume of blood, this size increase is contrary to the recognized advantages of having a low-profile catheter.